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Related Experiment Videos

Quantitative crystallinity determinations for beta-lactam antibiotics by solution calorimetry: correlations with

M J Pikal, A L Lukes, J E Lang

    Journal of Pharmaceutical Sciences
    |June 1, 1978
    PubMed
    Summary

    Solution calorimetry precisely measures relative crystallinity in amorphous and crystalline drug forms. This method correlates well with chemical stability when appropriate standards are used.

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    Area of Science:

    • Pharmaceutical Sciences
    • Physical Chemistry
    • Materials Science

    Background:

    • Amorphous forms of drugs possess higher energy than crystalline forms.
    • Solution calorimetry leverages this energy difference to assess physical form.
    • Understanding drug crystallinity impacts stability and bioavailability.

    Purpose of the Study:

    • To evaluate the utility and validity of solution calorimetry for assessing drug crystallinity.
    • To compare calorimetric crystallinity with X-ray diffraction and thermal decomposition data.
    • To establish the correlation between calorimetric crystallinity and chemical stability for specific cephalosporin sodium salts.

    Main Methods:

    • Preparation and characterization of amorphous, partially crystalline, and crystalline forms of cephalothin sodium, cefazolin sodium, cefamandole nafate, and cefamandole sodium.

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  • Powder X-ray diffraction (PXRD) for structural analysis.
  • Solution calorimetry to determine heat of solution and relative energy.
  • Thermal decomposition rate analysis for cephalothin sodium.

    • Main Results:

    • Good qualitative correlation observed between calorimetric and X-ray diffraction-derived crystallinity.
    • Heat of solution provides a precise (+/- 1%) and unambiguous measure of relative crystallinity.
    • Sample history influences the energy and structure of the amorphous state and crystalline polymorphs.
    • Calorimetric crystallinity correlates well with chemical stability when appropriate standards are selected.

    Conclusions:

    • Solution calorimetry is a valid and precise method for quantifying relative drug crystallinity.
    • The method's accuracy depends on the appropriate selection of amorphous and crystalline standards.
    • Calorimetric assessment of crystallinity is a reliable predictor of chemical stability for cephalosporin sodium salts.